1. Field of the Invention
The invention relates to a treatment system and device for treating gastro-esophageal reflux, and more particularly, the invention relates to a minimally invasive method and device for performing fundoplication.
2. Brief Description of the Related Art
A common condition that affects many people is heartburn. This condition occurs in as much as half of the U.S. population. Daily heartburn may occur in as many as 10 percent of U.S. population. Heartburn is caused by stomach acid reflux which causes stomach acid to enter the esophagus resulting in pain and discomfort. Prolonged contact of the esophagus to stomach acid results in a condition known as Barrett""s esophagus. This condition can be pre-cancerous.
Gastro-esophageal reflux disease (G.E.R.D.) is thought to be due to a condition where the lower esophageal sphincter becomes loose over time because of stretching and ageing. This lower esophageal sphincter is formed by the hiatus were the esophagus passes through the diaphragm. As the diaphragm becomes loose, the ability of the diaphragm to put adequate pressure on the esophagus to close it and prevent stomach acid from passing back up past the diaphragm becomes diminished. If the esophagus cannot be adequately compressed, acid is allowed to reflux into the esophagus from the stomach. This is especially true when the patient is supine, has a full stomach, or both.
Currently there are two established solutions for this problem. The first and most commonly used solution is to prescribe medications to either neutralize the acid or to eliminate its production altogether. These medications can be quite expensive, costing between about one thousand and three thousand dollars per year. There also is some controversy whether these medications prevent the cancerous condition in the esophagus. The other alternative is to have surgery. The surgery generally consists of wrapping the stomach or part of the stomach around the esophagus and fixing it in place. The surgery can be accomplished either through a large incision made in the abdomen or through minimally invasive surgery using a laparoscope. Both kinds of surgery require a general anesthetic and usually take between four and eight hours to accomplish. In addition, laparoscopic surgery requires a great deal of surgical skill.
From an economic perspective, surgical treatment requires that a specific physician, usually a gastroenterologist, diagnose the patient and then refer the patient to another physician, usually a general surgeon, for the corrective procedure at a later date. Because the gastroenterologist cannot perform the surgery himself, there is a natural tendency for the gastroenterologist to simply prescribe medication for the patient rather than recommending surgery. Because the patient must take the medication daily, there are a large number of patients who are unsatisfied with this treatment regimen. If a simplified curative surgical procedure were available, which the gastroenterologist could perform in his office at the time that the diagnosis is made, patients would generally opt for the procedure. Therefore, there is a need for devices and methods for their use, which would allow the gastroenterologist to perform the fundoplication procedure to eliminate gastric acid reflux into the esophagus.
The surgical procedure currently performed for these conditions is commonly referred to as the Nissen fundoplication. This procedure entails the placement of approximately 5 surgical insertion ports into the patient at various locations throughout the abdomen. Instruments are inserted and removed through the ports while visualizing the tips of the instruments inside the patient by means of a camera inserted through one of the ports. The instruments are used to cut and mobilize tissue from around the stomach so that it may be twisted around the esophagus. The stomach is wrapped around the esophagus and is then sutured in place at approximately one end of the stomach, such that a cuff is formed around the lower esophagus. This cuff of stomach around the esophagus may serve as a spacer so that the lower esophagus may be closed by the diaphragmatic muscles through which the lower esophagus passes. Alternatively, it may help to twist the stomach into the shape of a sphincter to close the opening back into the esophagus.
This type of surgery is usually very successful. One complication that may occur, however, includes the inability to swallow because the cuff is too tight around the esophagus. Another common complication is the inability to belch, or relieve gas and pressure from the stomach. Finally, when a long period of time has passed after the surgery, the cuff may slowly slip off the bottom of the lower esophagus, which allows acid to reflux into the esophagus again.
Two recent innovations allow for the stomach to be invaginated into the esophagus. According to one method an instrument is placed into the esophagus and expanded into the stomach and the stomach is perforated with the instrument. The stomach is then pulled into the esophagus. This allegedly creates an artificial valve in the esophagus. In one recently issued patent, U.S. Pat. No. 5,787,897, a device is inserted through the esophagus and into the stomach. This device as shown in the patent can be flexed and rotated to allow manipulation of the stomach around the esophagus. As shown in the patent, laparoscopic abdominal access is required in order to accomplish this procedure. As the stomach is held in place with the instrument inserted through the esophagus, laparoscopic surgical procedures are used to suture the stomach in place. This procedure still requires that the patient be under general anesthesia.
It would be desirable to provide a simplified method for the fundoplication procedure that can be performed by the gastroenterologist entirely through the esophagus without the need for general anesthesia.
The present invention relates to a device and method for performing fundoplication in which the treatment is performed entirely through the esophagus of the patient without making incisions into the abdomen or stomach.
According to one aspect of the invention, a device for performing fundoplication includes a first elongated member that is adapted to be positioned inside of an esophagus and a stomach, the first elongated member having a distal flexible portion having a first retracted configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape. The device also includes a second elongated member that is located adjacent to the first elongated member and is adapted to be positioned inside of the esophagus and the stomach, the second elongated member having a proximal flexible portion and a distal flexible portion, the proximal flexible portion having a first expanded configuration and a second expanded configuration, the second expanded configuration defining an arcuate shape, the distal flexible portion having a first retracted configuration and a second expanded configuration defining an arcuate shape, the proximal flexible portion and the distal flexible portion being coaxially aligned with each other when in the first retracted configuration.
Another aspect of the present invention discloses a method of performing a fundoplication procedure, including the steps of contacting a fundus portion of the stomach with an elongate member and moving the fundus portion of the stomach around the esophagus. After the fundus portion of the stomach is moved around the esophagus, the fundus portion is fastened to a different portion of the stomach.
The present invention does not require perforation of the stomach in order to manipulate it into position. This innovation is important because the contents of the stomach, if allowed to leak into the abdominal cavity, could cause severe harm to the patient. The present invention also differs substantially from all other procedures known in the prior art because it does not require laparoscopic access to the abdomen and, due to it""s simplicity, does not require internal transabdominal visualization or general anesthesia.